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| Name | Class |
|---|---|
| Egyptian Military Medical Services | OTHER_GOV |
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The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.
The World Health Organization (WHO) declared the coronavirus (SARS-CoV-2, COVID-19) outbreak a Public Health Emergency of International Concern with a pandemic spread. The situation is rapidly evolving, which raises the approach of reproposing already approved drugs to meet the emerging challenge and to save time and money. Lactoferrin (Lf) is a natural glycoprotein that broadly distributed within the body fluids and found predominantly in milk. It represents a known component of the innate immune system. The antiviral activity of Lf has been reported against many viruses, including SARS-CoV-1, through blocking the viral receptors on the host cells preventing them from entry and replication. Markedly, data reveals that Lf interacts with Heparan Sulfate Proteoglycans (HSPGs) and Angiotensin Converting Enzyme 2 (ACE2) receptors that are reported as SARS-CoV-2-binding sites to enter the host cell, suggesting a potential significance of Lf as an antiviral against SARS-CoV-2. Moreover, the immunoregulatory effects of Lf can protect against the cytokine-storm and thrombotic complications that result from the COVID-19-induced over-stimulated inflammatory response and exaggerated immune reactions. In addition, Lf can decrease the free iron toxicity caused by the virus as it has a strong iron chelating ability. Lf is a safe approved food supplement that is available in the markets for enhancement of immunity and for treatment of anemia. The aim of this study is to perform a randomized, double-blind, placebo-controlled, two arms, clinical trial to assess oral enteric-coated tablet of bovine apolactoferrin (the low iron-content form of Lf) as a safe antiviral and immunoregulatory therapy in patients diagnosed with COVID-19 disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 01 (SOC + Lactoferrin 1200 mg QID) | Active Comparator | Patients randomized to this group will receive two 600 mg Lactoferrin tablets QID plus the Standard of Care (SOC) treatment(s). |
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| Arm 02 (SOC + Placebo QID) | Placebo Comparator | Patients randomized to this group will receive two placebo tablets QID plus the SOC treatment(s). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin (Apolactoferrin) | Dietary Supplement | Apolactoferrin is an iron-free Lactoferrin (with very low iron saturation). Lactoferrin (Lf) is a natural glycoprotein that is found predominantly in milk. Lf represents a known component of the innate immune system present in neutrophil-specific granules and broadly distributed within the body fluids and exocrine secretions. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate. | Comparing the influence of the intervention on the Survival rate. | up to 8 weeks. |
| Rate of disease remission. | For mild/moderate symptoms patients: fever, cough and other symptoms relieved with improved lung CT - For severe symptoms patients: fever, cough and other symptoms relieved with improved lung CT, and oxygen saturation by pulse oximetry (SPO2 )> 93% for nonasthmatic patients, and from 88-92% in asthmatic patients. | up to 4 weeks. |
| The number of patients with PCR negative results. | Comparing the influence of the intervention on the PCR negative results. | up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the disease severity (clinical assessment). | Recording the changes from severe to moderate or mild and the time taken. | up to 4 weeks. |
| Mean change in blood pressure. | Recording the changes in blood pressure mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rehab Hegazy, PhD | Contact | +201001507676 | rehab_hegazy@hotmail.com | |
| Osama Azmy, MD | Contact | +201223103084 | osamaazmy@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Rehab Hegazy, PhD | National Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center, Egypt (Clinical and Molecular Pharmacology) | Cairo | Giza Governorate | 12622 | Egypt |
Not yet decided.
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within 6 month
all valid data
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Randomized, double-blind, placebo-controlled, clinical trial.
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| Placebo of excipient(s) will be administered | Drug | Placebo of the equivalent excipient will be administered to placebo group |
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| up to 4 weeks. |
| Mean change in heart beats. | Recording the changes in heart rate in beat/second. | up to 4 weeks. |
| Mean change in body temperature. | Recording the changes in body temperature in Celsius. | up to 4 weeks. |
| Mean change in body respiratory rate. | Recording the changes in the respiratory rate in breath/minute. | up to 4 weeks. |
| Mean change in oxygen saturation. | Recording the changes in arterial oxygen saturation in mmHg. | up to 4 weeks. |
| Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio). | Recording the changes in the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PF ratio). | up to 4 weeks. |
| Mean change in complete blood picture (CBC). | Recording the changes in complete blood picture (CBC) in cells per liter. | up to 4 weeks. |
| Mean change in C reactive protein (CRP). | Recording the changes in C reactive protein (CRP) in mg/L. | up to 4 weeks. |
| Mean change in erythrocyte sedimentation rate (ESR). | Recording the changes in erythrocyte sedimentation rate (ESR) in mm/hr. | up to 4 weeks. |
| Mean change in D-dimer. | Recording the changes in D-dimer in ng/mL. | up to 4 weeks. |
| Mean change in ferritin. | Recording the changes in ferritin in ng/mL. | up to 4 weeks. |
| Mean change in liver Albumin. | Recording the changes in liver Albumin in g/L. | up to 4 weeks. |
| Mean change in total and direct Bilirubin. | Recording the changes in total and direct Bilirubin in mg/dL. | up to 4 weeks. |
| Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ). | Recording the changes in prothrombin time (PT), partial thromboplastin time (PTT ) in seconds and calculating International Normalized Ratio (INR). | up to 4 weeks. |
| Mean change in aspartate aminotransferase (AST). | Recording the changes in aspartate aminotransferase (AST) in IU/L. | up to 4 weeks. |
| Mean change in Alanine Aminotransferase (ALT). | Recording the changes in Alanine Aminotransferase (ALT) in IU/L. | up to 4 weeks. |
| Mean change in Blood Urea Nitrogen (BUN). | Recording the changes in Blood Urea Nitrogen (BUN) in mg/dL. | up to 4 weeks. |
| Mean change in Serum Creatinine. | Recording the changes in Serum Creatinine in mg/dL. | up to 4 weeks. |
| Mean change in Serum Creatinine clearance. | Recording the changes in Serum Creatinine in ml/min. | up to 4 weeks. |
| Mean change in Glomerular filtration rate (GFR ). | Recording the changes in Glomerular filtration rate (GFR ) ml/min/m2. | up to 4 weeks. |
| The mean change in serum interleukin-1 (IL-1). | Recording the changes in interleukin-1 (IL-1) in pg/ml. | up to 4 weeks. |
| The mean change in serum interleukin-6 (IL-6). | Recording the changes in interleukin-6 (IL-6) in pg/ml. | up to 4 weeks. |
| The mean change in serum interleukin-10 (IL-10). | Recording the changes in interleukin-10 (IL-10) in pg/ml. | up to 4 weeks. |
| The mean change in serum tumor necrosis factor-alpha (TNF alpha). | Recording the changes in tumor necrosis factor-alpha (TNF alpha) in ng/ml. | up to 4 weeks. |
| Mean changes in immunoglobulin G (IgG). | Recording the changes in immunoglobulin G (IgG) in ng/ml. | up to 4 weeks. |
| Mean changes in immunoglobulin M (IgM). | Recording the changes in immunoglobulin M (IgM) in ng/ml. | up to 4 weeks. |
| The mean change in PCR viral load. | Recording the changes in PCR viral load in copies/mL. | up to 4 weeks. |
| Mean change in lung CT manifestation. | Recording the changes in lung CT. | up to 4 weeks. |
| Nature and severity of Adverse Events. | Recording any unexpected Adverse Events of the intervention. | up to 4 weeks. |
| Time for lung recovery. | Recording the changes (the average time of lung imaging recovery), as assessed by lung CT. | up to 8 weeks. |
| The number of missed drug doses among each treatment group. | Recording the changes the event of missed drug doses. | up to 4 weeks. |
| Clinmax CRO (Clinical Research Organization) | Cairo | 11835 | Egypt |
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| Clinical Trial Unit National Research Center | Cairo | Egypt |
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| Egyptian Military Medical Services (Hospitals) | Cairo | Egypt |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| C039223 | apolactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |
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